Trial · NCT03290248
Study to Assess the Safety, Tolerability, and Preliminary Efficacy of B244 in Healthy Volunteers and Subjects With Seasonal Allergic Rhinitis
NCT03290248, Phase 1, Phase 2, Completed, AOBiome LLC; results first posted 2022-11-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Safety, Tolerability, and Preliminary Efficacy of B244 in Healthy Volunteers and Subjects With Seasonal Allergic Rhinitis. Trials, record NCT03290248. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03290248
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Safety, Tolerability, and Preliminary Efficacy of B244 in Healthy Volunteers and Subjects With Seasonal Allergic Rhinitis
- NCT number
- NCT03290248
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 71 participants, actual
- Lead sponsor
- AOBiome LLC
- Conditions
- Allergic Rhinitis, Allergic Rhinitis Due to Grass Pollen, Healthy Volunteers
- Interventions
- B244 suspension, Vehicle
- First posted
- 2017-09-21
- Last updated
- 2022-11-25
- Results first posted
- 2022-11-25
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Baseline to Day 28 | Safety and tolerability endpoints will consist of all treatment-related adverse events reporting during the study duration for subjects only from Part 1 of the study. |
| Secondary | Change in Total Nasal Symptom Score (TNSS) After Prophylaxis Treatment | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | Total Nasal Symptom Score (TNSS) is the sum of sub-scores for each of nasal congestion, sneezing, nasal itching, and rhinorrhea at each time point, using a four point scale (0-3; 0 = none; 1 = mild; 2 = moderate; 3 = severe), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the sub-score for each of the symptoms to a total out of 12. For TNSS and Area Under the Curve (AUC) analyses, an Analysis of Covariance with treatment and site as factors and Visit 3 (or Visit 2) value as a covariate was used to test for treatment effect at Visit 4. Observed AUC (0-2 Hours) was defined as TNSS from 0 to 120 minutes post Nasal Allergen Challenge (NAC). The Pre-NAC Adjusted AUC (0-2 Hours) was defined as the observed value minus the 0 minutes prior NAC value. |
| Secondary | Subjective Nasal Symptom Scores of Nasal Congestion After Prophylaxis Treatment | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Nasal congestion was categorized as None, Mild, Moderate, or Severe. |
| Secondary | Subjective Nasal Symptom Scores of Rhinorrhea After Prophylaxis Treatment | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Rhinorrhea was categorized as None, Mild, Moderate, or Severe. |
| Secondary | Subjective Nasal Symptom Scores of Nasal Itching After Prophylaxis Treatment | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Nasal itching was categorized as None, Mild, Moderate, or Severe. |
| Secondary | Subjective Nasal Symptom Scores of Sneezing After Prophylaxis Treatment | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Sneezing was categorized as None, Mild, Moderate, or Severe. |
| Secondary | Nasal Symptom-free Response Rate in Nasal Congestion Scores After Prophylaxis Treatment | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to nasal congestion at Visit 4 (yes indicates subject is free from nasal congestion symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. |
| Secondary | Nasal Symptom-free Response Rate in Rhinorrhea Scores After Prophylaxis Treatment | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to rhinorrhea at Visit 4 (yes indicates subject is free from rhinorrhea symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. |
| Secondary | Nasal Symptom-free Response Rate in Nasal Itching Scores After Prophylaxis Treatment | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to nasal itching at Visit 4 (yes indicates subject is free from nasal itching symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. |
| Secondary | Nasal Symptom-free Response Rate in Sneezing Scores After Prophylaxis Treatment | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to sneezing at Visit 4 (yes indicates subject is free from sneezing symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Baseline to Day 28 | Population included subjects from Part 1 of the study and those who had received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Total Nasal Symptom Score (TNSS) After Prophylaxis Treatment | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | Population includes only patients from Part 2 of the study. | score on a scale*hours | MEAN |
| SECONDARY | Subjective Nasal Symptom Scores of Nasal Congestion After Prophylaxis Treatment | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | Population includes only patients from Part 2 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Subjective Nasal Symptom Scores of Rhinorrhea After Prophylaxis Treatment | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | Population includes only patients from Part 2 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Subjective Nasal Symptom Scores of Nasal Itching After Prophylaxis Treatment | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | Population includes only patients from Part 2 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Subjective Nasal Symptom Scores of Sneezing After Prophylaxis Treatment | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | Population includes only patients from Part 2 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Nasal Symptom-free Response Rate in Nasal Congestion Scores After Prophylaxis Treatment | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | Population includes only patients from Part 2 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Nasal Symptom-free Response Rate in Rhinorrhea Scores After Prophylaxis Treatment | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | Population includes only patients from Part 2 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Nasal Symptom-free Response Rate in Nasal Itching Scores After Prophylaxis Treatment | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | Population includes only patients from Part 2 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Nasal Symptom-free Response Rate in Sneezing Scores After Prophylaxis Treatment | Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects. | Population includes only patients from Part 2 of the study. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group243
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Vehicle | Drug Related TEAE | 0 | Participants | |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | B 244 1x (Low Dose) | Drug Related TEAE | 0 | Participants | |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | B244 4x (Mid Dose) | Drug Related TEAE | 0 | Participants | |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Vehicle | Drug Related Severe TEAE | 0 | Participants | |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | B 244 1x (Low Dose) | Drug Related Severe TEAE | 0 | Participants | |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | B244 4x (Mid Dose) | Drug Related Severe TEAE | 0 | Participants | |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Vehicle | Drug Related Serious TEAE | 0 | Participants | |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | B 244 1x (Low Dose) | Drug Related Serious TEAE | 0 | Participants | |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | B244 4x (Mid Dose) | Drug Related Serious TEAE | 0 | Participants | |
| Change in Total Nasal Symptom Score (TNSS) After Prophylaxis Treatment | Vehicle | Observed AUC (0-2 Hours) | -5.1 | Standard Deviation 3.53 | score on a scale*hours |
1 to 10 of 243Source ClinicalTrials.gov
See all 243 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Study Part 1 | STARTED | Vehicle | 8 | |
| Study Part 1 | STARTED | B 244 1x (Low Dose) | 8 | |
| Study Part 1 | STARTED | B244 4x (Mid Dose) | 8 | |
| Study Part 1 | COMPLETED | Vehicle | 8 | |
| Study Part 1 | COMPLETED | B 244 1x (Low Dose) | 8 | |
| Study Part 1 | COMPLETED | B244 4x (Mid Dose) | 8 | |
| Study Part 1 | NOT COMPLETED | Vehicle | 0 | |
| Study Part 1 | NOT COMPLETED | B 244 1x (Low Dose) | 0 | |
| Study Part 1 | NOT COMPLETED | B244 4x (Mid Dose) | 0 | |
| Study Part 2 | STARTED | Vehicle | 15 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ear congestion | Ear and labyrinth disorders | Part 1: Vehicle | 0 | 8 | |
| other | Ear congestion | Ear and labyrinth disorders | Part 1: B244 1x (Low Dose) | 0 | 8 | |
| other | Ear congestion | Ear and labyrinth disorders | Part 1: B244 4x (Mid Dose) | 0 | 8 | |
| other | Ear congestion | Ear and labyrinth disorders | Part 2: Vehicle | 0 | 15 | |
| other | Ear congestion | Ear and labyrinth disorders | Part 2: B244 1x (Low Dose) | 0 | 16 | |
| other | Ear congestion | Ear and labyrinth disorders | Part 2: B244 4x (Mid Dose) | 1 | 16 | |
| other | Chest discomfort | General disorders | Part 1: Vehicle | 0 | 8 | |
| other | Chest discomfort | General disorders | Part 1: B244 1x (Low Dose) | 0 | 8 | |
| other | Chest discomfort | General disorders | Part 1: B244 4x (Mid Dose) | 0 | 8 | |
| other | Chest discomfort | General disorders | Part 2: Vehicle | 0 | 15 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Vehicle | 0 | 8 |
| Total, all-cause mortality | Part 1: B244 1x (Low Dose) | 0 | 8 |
| Total, all-cause mortality | Part 1: B244 4x (Mid Dose) | 0 | 8 |
| Total, all-cause mortality | Part 2: Vehicle | 0 | 15 |
| Total, all-cause mortality | Part 2: B244 1x (Low Dose) | 0 | 16 |
| Total, all-cause mortality | Part 2: B244 4x (Mid Dose) | 0 | 16 |
| Total, other adverse events | Part 1: Vehicle | 1 | 8 |
| Total, other adverse events | Part 1: B244 1x (Low Dose) | 1 | 8 |
| Total, other adverse events | Part 1: B244 4x (Mid Dose) | 1 | 8 |
| Total, other adverse events | Part 2: Vehicle | 1 | 15 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03290248
GET https://conductscience.org/api/trials/v1/NCT03290248/results?page=2